Scientific Review Committees as part of institutional review of human participant research: Initial implementation at institutions with Clinical and Translational Science Awards. Issue 2 (27th April 2020)

• Record Type: Journal Article
• Authors: Selker, Harry P.; Welch, Lisa C.; Patchen-Fowler, Elizabeth; Breeze, Janis L.; Terrin, Norma; Parajulee, Anshu; LeClair, Amy; Naeim, Arash; Marnocha, Rebecca; Morelli Novak, Julie; Caldwell, Christine Sego; Cola, Philip A.; Croker, Jennifer A.; Cifu, David X.; Williams, Kirsten M.; Snyder, Denise C.; Kitterman, Darlene
• Is Part Of: Journal of clinical and translational science. Volume 4:Issue 2(2020)
• Page Start: 115
• Page End: 124
• Publication Date: 2020-04-27
• Subjects: Ethics review, -- Scientific Review Committee, -- scientific quality, -- operational feasibility, -- quantitative and qualitative methods; Clinical medicine -- Research -- Periodicals; Medicine, Experimental -- Periodicals; Human experimentation in medicine -- Periodicals; 616.027
• DOI: 10.1017/cts.2019.439
• Languages: English
• ISSNs: 2059-8661

Abstract

Abstract: Introduction: Scientific quality and feasibility are part of ethics review by Institutional Review Boards (IRBs). Scientific Review Committees (SRCs) were proposed to facilitate this assessment by the Clinical and Translational Science Award (CTSA) SRC Consensus Group. This study assessed SRC feasibility and impact at CTSA-affiliated academic health centers (AHCs). Methods: SRC implementation at 10 AHCs was assessed pre/post-intervention using quantitative and qualitative methods. Pre-intervention, four AHCs had no SRC, and six had at least one SRC needing modifications to better align with Consensus Group recommendations. Results: Facilitators of successful SRC implementation included broad-based communication, an external motivator, senior-level support, and committed SRC reviewers. Barriers included limited resources and staffing, variable local mandates, limited SRC authority, lack of anticipated benefit, and operational challenges. Research protocol quality did not differ significantly between study periods, but respondents suggested positive effects. During intervention, median total review duration did not lengthen for the 40% of protocols approved within 3 weeks. For the 60% under review after 3 weeks, review was lengthened primarily due to longer IRB review for SRC-reviewed protocols. Site interviews recommended designing locally effective SRC processes, building buy-in by communication or by mandate, allowing time for planning and sharing best practices, and connecting SRC and IRB procedures. Conclusions: The CTSA SRC Consensus Group recommendations appear feasible. Although not conclusive in this relatively short initial implementation, sites perceived positive impact by SRCs on study quality. Optimal benefit will require local or federal mandate for implementation, adapting processes to local contexts, and employing SRC stipulations.